Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136539
• Other study ID #: 98-222
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2005
• Last updated: February 15, 2013
• Start date: March 1999
• Est. completion date: March 2012

Study information

• Verified date: February 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Description:

Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10).

After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy).

Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total).

After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram.

At the time of surgery, re-assessment of the tumor will be done.

Blood work will be performed on day one of each chemotherapy cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2012
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have Stage II or III histologically diagnosed breast cancer

• Primary invasive breast cancers that overexpress the HER2/neu oncogene

• Age older than 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status of < 1

• White blood cell (WBC) > 4000/mm3

• Platelet count > 100,000/mm3

• Bilirubin < 1 x upper limit of normal (ULN)

• SGOT < 1 x ULN

• Creatinine < 1.5mg/dl

• Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy

Exclusion Criteria:

• Excisional biopsy, sentinel node dissection or axillary node dissection.

• Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.

• Pregnant or breast-feeding women

• Uncontrolled infection

• Active or severe cardiovascular or pulmonary disease

• Peripheral neuropathy of any etiology that exceeds grade 1

• Prior history of malignancy treated without curative intent

• Uncontrolled diabetes

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Herceptin
Given intravenously once weekly for 12 weeks prior to surgery.
• Taxol
Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
• Adriamycin
Given every three weeks for 12 weeks after surgery.
• Cytoxan
Given every three weeks for 12 weeks after surgery.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Harold J. Burstein, MD, PhD	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Bristol-Myers Squibb, Dana-Farber Cancer Institute, Genentech, Inc., Harvard Vanguard Medical Associates, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery		TBD	No
Secondary	To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy		3 years	Yes